A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD

Syntara

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Exacerbation; COPD

Treatments: Drug: mannitol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00446667

DPM-COPD-HIP-101b

Details and patient eligibility

About

COPD is a major cause of ill health and death in Australia with 40,000 hospital admissions, and a national cost of $898,000,000 annually. The gold standard treatment of COPD is steroids for inflammation, antibiotics for infection and bronchodilators and oxygen for respiratory failure. However, associated mucus hypersecretion is responsible for much of the inflammation and infection. The use of pharmaceutical agents to assist in the early clearance of the retained mucus has been limited, primarily because of lack of demonstrated effect. There has been a recent development of interest in pursuing new therapies for improving mucociliary clearance and several studies have demonstrated that clinical outcomes can be improved when osmotic agents such as mannitol are added to standard treatments. The purpose of this study is to conduct a pilot safety study in patients with an acute exacerbation of COPD to determine if it is safe to administer inhaled mannitol for facilitating mucus clearance.

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• FEV1 > 35% predicted
• COPD
• Exacerbation
• Inpatient

Exclusion criteria

• Pneumonia
• CO2 retention

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1

Experimental group

Treatment:

Drug: mannitol